MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX AST BROTH, 4.5 ML; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number 246011

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

It was reported that while using 2 bd phoenix¿ ast broth, 4.5 ml mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that 2 broth contamination with mold.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: this complaint is for phoenix ast broth (246011) batch 0324821 that contained contaminated tubes.No photos were provided, however 90 sample tubes were returned by the customer.For investigation, tubes were sent to qc micro for id.The isolates were identified as madurella grisea and penicillium species.Based on the analysis of the samples provided, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on this complaint batch.A review of complaints was performed and there were no additional complaints filed for this batch.Complaint trending was performed and no trends were identified associated with the complaint batch or defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that while using 2 bd phoenix¿ ast broth, 4.5 ml mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that 2 broth contamination with mold.".

• Brand Name: BD PHOENIX AST BROTH, 4.5 ML
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11837568
• MDR Text Key: 280843093
• Report Number: 1119779-2021-00843
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460115
• UDI-Public: 30382902460115
• Combination Product (y/n): N
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/05/2021
• Device Model Number: 246011
• Device Catalogue Number: 246011
• Device Lot Number: 0324821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1